Triamcinolone Nanocapsules After Endoscopic Nasal Surgery

Официальное название

Clinical Evaluation of Triamcinolone Acetonide-loaded Nanoparticles For Nasal Postoperative Application

Обзор

This randomised, single-masked, parallel-group clinical trial will evaluate the efficacy and safety of a topical triamcinolone acetonide-loaded polymeric nanocapsule formulation for postoperative care following endoscopic nasal surgery. Participants will receive either the investigational triamcinolone acetonide-loaded nanocapsule formulation or standard normal saline nasal irrigation. Postoperative nasal healing, inflammation, patient-reported sinonasal symptoms, postoperative complications, and corticosteroid-related adverse effects will be compared between the two groups.

Подробное описание

Postoperative care following functional endoscopic sinus surgery and other endoscopic nasal procedures is important for reducing inflammation, supporting mucosal healing, and preventing complications and disease recurrence.

Conventional topical nasal treatments may be rapidly cleared from the nasal cavity, which may reduce their contact time with the postoperative nasal mucosa.

The investigational formulation contains triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method. The nanocapsule delivery system is intended to improve local drug retention, enhance drug stability, and provide controlled release of triamcinolone acetonide at the postoperative nasal tissues.

Eligible participants will be randomly assigned to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery.

Participants will be followed using endoscopic clinical assessments, patient-reported sinonasal symptom questionnaires, evaluation of postoperative complications, and monitoring for local or systemic corticosteroid-related adverse effects.

Вмешательства

• Препарат Triamcinolone Acetonide-Loaded Polymeric Nanocapsules
  Triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method will be administered topically to the postoperative nasal cavity.
• Другое Normal Saline Nasal Irrigation
  Participants will receive postoperative nasal irrigation with 0.9% sodium chloride solution.

Первичные конечные точки

• Change in Lund-Kennedy Endoscopic Score [Срок оценки: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3]
• Change in 22-Item Sinonasal Outcome Test Score (SNOT-22) [Срок оценки: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3]

Вторичные конечные точки (2)

• Incidence of Postoperative Complications [Срок оценки: From the date of surgery through postoperative month 3]
• Incidence of Corticosteroid-Related Adverse Events [Срок оценки: From the first administration of study treatment through postoperative month 3]

Критерии участия

Критерии включения

• Adults aged 18 to 60 years.
• Patients scheduled to undergo one of the following procedures:
• Functional endoscopic sinus surgery
• Endoscopic turbinoplasty
• Endoscopic septoplasty
• Diagnosis of chronic rhinosinusitis and/or nasal polyps requiring surgical intervention.
• Ability and willingness to provide written informed consent.
• Ability and willingness to comply with study treatment and scheduled follow-up visits.

Критерии исключения

• Known hypersensitivity to triamcinolone acetonide.
• Known hypersensitivity to any component of the polymeric nanocapsule formulation.
• Systemic contraindication to corticosteroid therapy.
• Active severe nasal or sinonasal infection at the time of enrollment or treatment.
• Pregnancy or breastfeeding, if excluded in the approved protocol.
• Uncontrolled diabetes mellitus, if corticosteroid exposure is considered clinically relevant.
• Immunosuppression or use of immunosuppressive therapy.
• Recent use of systemic or intranasal corticosteroids within the protocol-defined washout period.
• Participation in another clinical trial.
• Any medical or psychiatric condition that may interfere with informed consent, study treatment, or follow-up.
• Inability to complete the required questionnaires or follow-up visits.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Deraya university, faculty of pharmacy — Minya

Публикации

• Camargo GDA, Ferreira L, Schebelski DJ, Lyra AM, Barboza FM, Carletto B, Koga AY, Semianko BC, Dias DT, Lipinski LC, Novatski A, Raman V, Manfron J, Nadal JM, Farago PV. Characterization and In Vitro and In Vivo Evaluation of Tacrolimus-Loaded Poly(epsilon-Caprolactone) Nanocapsules for the Management of Atopic Dermatitis. Pharmaceutics. 2021 Nov 26;13(12):2013. doi: 10.3390/pharmaceutics13122013. PMID 34959295
• Erdogar N, Akkin S, Bilensoy E. Nanocapsules for Drug Delivery: An Updated Review of the Last Decade. Recent Pat Drug Deliv Formul. 2018;12(4):252-266. doi: 10.2174/1872211313666190123153711. PMID 30674269
• Kothamasu P, Kanumur H, Ravur N, Maddu C, Parasuramrajam R, Thangavel S. Nanocapsules: the weapons for novel drug delivery systems. Bioimpacts. 2012;2(2):71-81. doi: 10.5681/bi.2012.011. Epub 2012 Apr 5. PMID 23678444
• Siebelt M, Korthagen N, Wei W, Groen H, Bastiaansen-Jenniskens Y, Muller C, Waarsing JH, de Jong M, Weinans H. Triamcinolone acetonide activates an anti-inflammatory and folate receptor-positive macrophage that prevents osteophytosis in vivo. Arthritis Res Ther. 2015 Dec 5;17:352. doi: 10.1186/s13075-015-0865-1. PMID 26637220
• Imai S, Otsuka T, Naito A, Shimazawa M, Hara H. Triamcinolone Acetonide Suppresses Inflammation and Facilitates Vascular Barrier Function in Human Retinal Microvascular Endothelial Cells. Curr Neurovasc Res. 2017;14(3):232-241. doi: 10.2174/1567202614666170619081929. PMID 28625129
• Bugten V, Nordgard S, Steinsvag S. Long-term effects of postoperative measures after sinus surgery. Eur Arch Otorhinolaryngol. 2008 May;265(5):531-7. doi: 10.1007/s00405-007-0501-z. Epub 2007 Oct 25. PMID 17960410
• Eloy P, Andrews P, Poirrier AL. Postoperative care in endoscopic sinus surgery: a critical review. Curr Opin Otolaryngol Head Neck Surg. 2017 Feb;25(1):35-42. doi: 10.1097/MOO.0000000000000332. PMID 27846022
• Rudmik L, Soler ZM, Orlandi RR, Stewart MG, Bhattacharyya N, Kennedy DW, Smith TL. Early postoperative care following endoscopic sinus surgery: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2011 Nov-Dec;1(6):417-30. doi: 10.1002/alr.20072. Epub 2011 Oct 29. PMID 22144050

Идентификаторы

NCT: NCT07714525 · DU-PH-NANO-RCT-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗